central IRB. She began with a brief description of the possible benefits of having a single IRB handle multisite studies. These include a more efficient IRB review process, with multiple sites being approved more quickly, and continuing review and amendments being handled more effectively; less duplication of reviews; and a more consistent review because a single IRB will be seeing all of the adverse events. Together, these benefits may help studies get under way more quickly, which may allow researchers to enroll participants more easily and increase their chances of completing their studies successfully.

However, O’Rourke said, having a single IRB for a multisite study simplifies only part of the process. In addition to IRB review, there are also ancillary committee reviews, such as those for conflict of interest, radiation safety, and biosafety; grants and contracts reviews; and institutional sign-off and responsibility for the local conduct of the research. Thus, there will remain a great deal of institutional involvement at each site even with a single IRB.

Types of Central IRBs

Among central, or single IRBs, there are two types: a share model and a nonshare model. In the nonshare model the central IRB fulfills all the IRB review requirements. It is responsible for the initial review, the continuing review, amendments, adverse event reporting, and so forth. In the share model, the central IRB and the local IRBs share some review responsibilities, most frequently regarding amendments and adverse events. O’Rourke suggested thinking of them as falling on a spectrum, with nonshare, central IRBs at one end of the spectrum and the situation in which there are only local IRBs at the other end. Commercial IRBs and IRBs in the Veterans Administration system tend to fall at the nonshare end of the spectrum, she noted. The status quo for most academic multisite studies is at the other end, with each site having its own IRB. The original National Cancer Institute IRB falls somewhere in the middle, she added, because the central IRB would do the initial review, but local IRBs reviewed local site amendments and local adverse events that were not too severe. In another type of share model, the IRBshare, there is “a sharing of documentation and review of what happened at the initial review, but basically everything reverts back to the local IRB once the protocol is up and running,” she explained.

IRB Versus Institutional Responsibilities

O’Rourke also noted that there are institutional responsibilities relating to research that are not handled by IRBs. Institutions are respon-



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